Better 8 years late than never: Merck KGaA nabs FDA nod for MS drug Mavenclad

Up to 10 years of safety data has paid off for Merck KGaA’s oral multiple sclerosis treatment Mavenclad. The drug has returned from the dead, eight years after an FDA rejection dashed its dream of challenging Novartis’ then-newly-minted Gilenya—and according to one analyst, it might just be a blockbuster. Maveclad (cladribine) is now approved to treat relapsing forms of MS, including relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS), the FDA said Friday. The agency's green light came after more than 50 other countries, including in the EU, had approved it. The Merck drug does carry a black box warning for an increased risk of cancer and birth defects, which pushed its FDA-approved use into the second line—in patients who don’t respond to or are unable to tolerate other MS drugs. But as Bernstein analyst Wimal Kapadia sees it, the safety profile is no reason to belittle Mavenclad’s success potential.